On February 23, 2018, IRIDEX Corporation initiated a voluntary recall of a specific laser accessory called the TruFocus LIO Premiere. The LIO is a headmounted indirect ophthalmoscope that connects to an IRIDEX laser console and is used to view and perform laser treatments on a patient’s eye. There are 104 TruFocus LIO Premiere units at customer sites worldwide. The company has received reports of three adverse events occurring during procedures in which the TruFocus LIO Premiere was used. These reports stated that the procedures resulted in patients experiencing permanent damage to the eye, including focal cataracts and iris burns.

Customers who have the TruFocus LIO Premiere should stop using it. IRIDEX is notifying its distributors and customers via FedEx and is arranging for return of all recalled products.

Recalled products were manufactured from May 26, 2017 to November 6, 2017 and distributed from June 5, 2017 to January 29, 2018.

The following part numbers have been recalled: 87300, 87301, 87302, 87303, and 87304.

IRIDEX has notified the U.S. Food and Drug Administration (FDA) of this action.

Customers with questions may contact the company at 1-844-357-9485 in the US and 1-650-962-8100 outside the US between the hours of 8:00 a.m. and 5:00 p.m. PT. Customers may also contact the company via e-mail at techsupport@iridex.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program.

As a consequence of this recall program, the company has revised its preliminary financial results for the fourth quarter and full year ended December 30, 2017 to the following:

Total revenue for the fourth quarter of 2017 is expected to be $10.2 to $10.3 million

Total revenue for 2017 is expected to be $41.5 to $41.6 million

IRIDEX expects to release its complete fourth quarter and full year 2017 results on Thursday, March 8, 2018 and will host a corresponding conference call beginning at 2:00 p.m. PT / 5:00 p.m. ET, at which time, the company plans to provide additional details regarding the financial impact of this recall program.

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